Liquid infusion pump

ABSTRACT

A method is provided for controlling change access to a display menu of an ambulatory liquid infusion pump. A programmed menu of the infusion pump may be displayed and a menu lock flag may be monitored. Changes to at least one active item of the programmed menu may be disabled if the menu lock flag is activated.

REFERENCE

This application is a continuation of PCT/US2008/066267 filed Jun. 9,2008 which is based on and claims priority to U.S. Provisional PatentApplication Ser. No. 60/937,779 and U.S. Provisional Patent ApplicationSer. No. 60/937,933, both filed Jun. 29, 2007. All applicationsidentified in this paragraph are hereby incorporated by reference.

FIELD

This disclosure relates generally to devices for selectively deliveringliquid to a living body, and more specifically to liquid infusion pumpsfor controllably delivering liquid to a living body.

BACKGROUND

Devices for selectively and controllably delivering liquid, such as adrug, to a living body are known. Such devices may typically beconfigured to controllably deliver the drug to the living body atdifferent rates during different times of the day and according to oneor more user selectable drug delivery profiles that may be programmed bythe user.

SUMMARY

The present invention may comprise one or more of the features recitedin the attached claims, and/or one or more of the following features andcombinations thereof. A method of controlling change access to a displaymenu of an ambulatory liquid infusion pump may comprise displaying aprogrammed menu of the infusion pump, monitoring a menu lock flag, anddisabling changes to at least one active item of the programmed menu ifthe menu lock flag is activated.

Disabling changes may comprise disabling changes to all active items ofthe programmed menu.

The method may further comprise displaying a warning message upondetection of attempted changes to the at least one active item of theprogrammed menu if the menu lock flag is activated.

The method may further comprise enabling changes to the at least oneactive item of the programmed menu if the menu lock flag is deactivated.

Enabling changes may comprise enabling changes to all of the activeitems of the programmed menu.

The method may be carried out on the ambulatory liquid infusion pump. Inthis embodiment, displaying may comprise displaying the programmed menuon a display device of the ambulatory liquid infusion pump.Alternatively or additionally, the method may be carried out on anelectronic device that is separate and remote from the ambulatory liquidinfusion pump. In this embodiment, displaying may comprise displayingthe programmed menu on a display device of the electronic device.

A first version of application software containing the menu may beavailable to users of the ambulatory liquid infusion pump, and a secondversion of the application software containing the menu may be availableonly to health care professionals. In one embodiment, the menu lock flagmay be activated in the first version of application software and may bedeactivated in the second version of the application software.Alternatively, the menu lock flag may be activated in the first versionof application software, and the second version of the applicationsoftware may not include the menu lock flag.

A method of extending a pre-programmed lifetime of an ambulatory liquidinfusion pump may comprise monitoring a pre-programmed lifetime timerresident in the liquid infusion pump, allowing the liquid infusion pumpto continue operating after the lifetime timer expires, and disablingoperation of the liquid infusion pump if a liquid infusion pumpoperating error is detected after the lifetime timer expires.

The method may further comprise displaying a message on a display deviceof the liquid infusion pump when the lifetime timer expires. The messagemay illustratively identify expiration of the lifetime of the liquidinfusion pump.

The method may further comprise activating at least one of an audibleindicator and a vibratory device when the lifetime timer expires.

A method of storing information relating to operation of a liquidinfusion pump may comprise periodically storing in a storage location ofa non-volatile memory information relating to delivery by the pump of acommanded liquid amount throughout delivery by the pump of the commandedliquid amount, transferring the information relating to delivery by thepump of the commanded liquid amount from the storage location of thenon-volatile memory to a pump history database when delivery by the pumpof the commanded liquid amount is complete, and automaticallytransferring any information relating to delivery by the pump of acommanded liquid amount that is accumulated in the storage location ofthe non-volatile memory to the pump history database upon power up ofthe liquid infusion pump.

The information relating to delivery by the pump of a commanded liquidamount may include any one or more of a delivered liquid quantity, apercentage of a delivered liquid quantity relative to 100%, one or moreassociated liquid delivery limits, a liquid delivery type, whether thedelivered liquid was locally or remotely commanded, and the time anddate of liquid delivery. The one or more liquid delivery limits mayillustratively include one or more of a maximum liquid amount, a minimumliquid amount, a maximum delivery duration and a minimum deliveryduration. The liquid delivery type may illustratively include at leastone of a basal rate, a temporary basal rate a standard bolus, anextended bolus, a multi-wave bolus and a quick bolus.

The method may further comprise clearing the non-volatile memory afterautomatically transferring information from the non-volatile memory tothe pump history database.

The commanded liquid amount may be one of a locally commanded liquidamount and a remotely commanded liquid amount.

In one embodiment, periodically storing information relating to deliveryby the pump of a commanded liquid amount throughout delivery by the pumpof the commanded liquid amount may comprise storing informationperiodically in time. Alternatively or additionally, periodicallystoring information relating to delivery by the pump of a commandedliquid amount throughout delivery by the pump of the commanded liquidamount may comprise storing the information after each delivery of bythe pump of an incremental amount of the commanded liquid amount.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a block diagram of one illustrative embodiment of awireless communication system including a liquid infusion pump and aremote electronic device that are both configured to wirelesslycommunicate with each other.

FIG. 2 shows a diagram of one illustrative embodiment of the liquidinfusion pump of FIG. 1.

FIG. 3 shows a diagram of the liquid infusion pump of FIG. 2 shown witha liquid cartridge inserted therein.

FIG. 4 shows a flowchart of one illustrative embodiment of a process forcontrolling change access to one or more active items of a displayedmenu.

FIG. 5 shows a flowchart of one illustrative embodiment of a process forextending the pre-programmed lifetime of the liquid infusion pump.

FIG. 6 shows a flowchart of one illustrative embodiment of a process forstoring current pump operating information in non-volatile memory duringand throughout delivery of a currently commanded liquid amount.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to a number of illustrativeembodiments shown in the attached drawings and specific language will beused to describe the same.

The following co-pending patent applications are incorporated herein byreference: PCT Patent Application No. PCT/US2008/066288, entitledAPPARATUS AND METHOD FOR REMOTELY CONTROLLING AN AMBULATORY MEDICALDEVICE; PCT Patent Application No. PCT/US2008/066262, entitledCOMBINATION COMMUNICATION DEVICE AND MEDICAL DEVICE FOR COMMUNICATINGWIRELESSLY WITH A REMOTE MEDICAL DEVICE; PCT Patent Application No.PCT/US2008/066331, entitled METHOD AND APPARATUS FOR DETERMINING ANDDELIVERING A DRUG BOLUS; PCT Patent Application No. PCT/US2008/066299,entitled USER INTERFACE FEATURES FOR AN ELECTRONIC DEVICE; PCT PatentApplication No. PCT/US2008/066247, entitled METHOD FOR PAIRING ANDAUTHENTICATING ONE OR MORE MEDICAL DEVICES AND ONE OR MORE REMOTEELECTRONIC DEVICES; PCT Patent Application No. PCT/US2008/066248,entitled DEVICE AND METHODS FOR OPTIMIZING COMMUNICATIONS BETWEEN AMEDICAL DEVICE AND A REMOTE ELECTRONIC DEVICE; and U.S. ProvisionalPatent Application Ser. No. 61/130,855, entitled DEVICE AND METHODS FOROPTIMIZING COMMUNICATIONS BETWEEN AN ELECTRONIC DEVICE AND A MEDICALDEVICE.

Referring now to FIG. 1, a block diagram is shown of one illustrativeembodiment of a wireless communication system 10 including a liquidinfusion pump 14 and a remote electronic device 12 that are bothconfigured to wirelessly communicate with each other. The electronicdevice 12 has a housing through which a user button section 16 extends.The user button section. 16 defines a number of user buttons, keys orswitches that may be manually manipulated by a user to provide input tothe remote electronic device 12. A visual display unit 18 is alsocarried by the housing of the electronic device 12. In one embodiment,the visual display unit 18 is provided in the form of a conventionalliquid crystal display (LCD), although this disclosure contemplatesusing other conventional display units. Examples include, but are notlimited to, plasma displays, light emitting diode (LED) based displays,vacuum fluorescent (VF) displays, and the like. In any case, the visualdisplay unit 18 is controlled by the electronic device 12 to displayinformation to a user of the device 12. The user buttons 16 and thedisplay device 18 are both electrically connected to a conventionalprocessor 20 that is also electrically connected to a conventionalwireless communication circuit or module 22. In some embodiments, theremote electronic device 12 may further include a conventional glucosemeter that is configured to receive therein a carrier upon which ananalyte containing liquid sample may be deposited. The remote electronicdevice 12 may be operable in a conventional manner to determine theconcentration of the analyte in the liquid sample, and to display theresult on the display unit 18 and/or use the result in one or morealgorithms executed by the processor 20.

The liquid infusion pump 14 has a conventional processor 28 thatincludes a conventional memory unit 25. In the illustrated embodiment,the infusion pump 14 further includes conventional non-volatile memoryunits 27 and 29. In one embodiment, the non-volatile memory unit 27 isprovided in the form of a conventional ferroelectric random accessmemory (FRAM) and the non-volatile memory unit 29 is provided in theform of a conventional electrically erasable programmable read onlymemory (EEPROM), although either memory unit 27, 29 may alternatively beprovided in the form of one or more other conventional non-volatilememory units. In any case, the memory units 27 and 29 are each externalto the processor 28 and are each electrically connected to the processor28. As will be described in greater detail hereinafter, the memory unit27 is a pump delivery (PD) memory unit in which the processor 28 storescurrent pump delivery information, and the memory unit 29 is a pumphistory (PH) memory unit that has stored therein pump historyinformation in a pump history database, e.g., in the form of eventrecords each corresponding to an operational event of the pump 14. Theprocessor 28 is also electrically connected to a wireless communicationcircuit or module 30. The wireless communication module 30 is configuredto communicate wirelessly with the wireless communication module 22 ofthe remote electronic device 12 via a wireless communication link 40 ina conventional manner. In one embodiment, as will be illustrated byexample throughout this disclosure, the wireless communication module 30and the wireless communication module 22 of the electronic device 12 areboth conventional BlueTooth® modules configured to wirelesslycommunicate according to a conventional BlueTooth® communicationprotocol. It will be understood, however, that the wirelesscommunication circuit or module 30 and the wireless communicationcircuit or module 22 of the electronic device 12 may alternatively beconfigured to wirelessly communicate according to one or more otherconventional communication protocols.

The processor 28 is also electrically connected to another wirelesscommunication circuit or module 35. The wireless communication circuit35 is configured to communicate wirelessly with another remoteelectronic device 15 via a wireless communication link 17 in aconventional manner. In one embodiment, the wireless communicationcircuit 35 includes a conventional infrared (IR) transceiver, and thewireless communication circuit 35 is configured to communicate with theelectronic device 15 via a conventional IR communications protocol. Inthis embodiment, the electronic device 15 also includes a conventionalIR transceiver, and the wireless communication link 17 is therefore anIR communication link. In one embodiment, the electronic device 15 is aconventional personal computer (PC), although the electronic device 15may alternatively be a conventional laptop, notebook or other computer,a personal data assistant (PDA) or the like. In the illustratedembodiment, the wireless communication circuit 35 is used by the liquidinfusion pump 14 to download pump-related data to the electronic device15 for analysis and/or observation. The wireless communication circuit35 may alternatively or additionally be used to download data or codefrom the electronic device 15, such as new software, software updates,software version updates or the like, pump configuration data, languagefiles, current time and data information, and the like. It will beunderstood, however, that while the wireless communication circuit 35has been described as including a conventional infrared transceiver, thewireless communication circuit 35 and the electronic device 15 mayalternatively or additionally be configured to wirelessly communicatevia other conventional media including for example, but not limited to,a radio frequency (RF) communication link, a microwave frequencycommunication link, inductive coupling, or the like.

The liquid infusion pump 14 includes a housing through which a number ofuser buttons 32 extend. The user buttons 32 may be provided in the formof any number of user selectable buttons, keys or switches that areelectrically connected to the processor 28. The liquid infusion pump 14further includes a visual display unit 34 that is carried by the housingand that is electrically connected to the processor 28. The visualdisplay unit 34 may be, for example, a conventional liquid crystaldisplay (LCD), plasma displays, light emitting diode (LED) baseddisplay, vacuum fluorescent (VF) display, or the like. The visualdisplay unit 34 is controlled by the processor 28 to display informationto a user of the liquid infusion pump 14.

The processor 28 of the liquid infusion pump 14 is further electricallyconnected to a conventional audible indication device 36 and/or to aconventional vibratory device 38. The processor 28 is generally operableto control the audible indication device 36 and/or the vibratory device38 to produce one or more audible sounds and/or vibrations respectivelyto notify the user of various operational aspects of the liquid infusionpump 14 and to also notify the user of any alarm and/or warningconditions associated with the liquid infusion pump 14. The memory unit25 has one or more sets of instructions stored therein that areexecutable by the processor 28 to carry out one or more processesassociated with the liquid infusion pump 14. The liquid infusion pump 14further includes a power supply 42 that is configured to derive a supplyvoltage from one or more chargeable or non-chargeable batteries 44, andto provide the supply voltage to at least the processor 28 and thewireless communication module 30. In one embodiment, the insulininfusion pump 14 uses a single AA 1.5V rechargeable battery or a lithiumor alkaline non-rechargeable battery, having a minimum capacity of 2500mAh, although this disclosure contemplates other embodiments which usemore, fewer and/or different chargeable and/or non-rechargeablebatteries. A conventional motor drive circuit 46 is electricallyconnected to the processor 28, and the motor drive circuit 46 isresponsive to control signals produced by the processor 28 to drive apump motor 48. In one embodiment, the pump motor 48 is a brushless DCmotor, although the pump motor 48 may alternatively be a conventional DCmotor or a stepper motor or other conventional drive mechanism.

Referring now to FIG. 2, a diagram is shown of one illustrativeembodiment of some of the exterior and/or readily visible features ofthe liquid infusion pump 14. In the illustrated embodiment, the pump 14has a housing 50 through which a display 34 extends. In alternativeembodiments, the pump 14 may not include a display and/or may includeother visual indicators such as one or more lamps, light emitting diodes(LEDs), or the like. The housing 50 defines a liquid cartridge chamber52 into which a conventional liquid drive mechanism 54 is configured toextend. In one embodiment, the liquid drive mechanism 54 is aconventional telescoping drive mechanism that is configured to movelinearly within the chamber 52, although this disclosure contemplatesalternative embodiments in which the liquid drive mechanism 54 rotatablyadvances into and out of the chamber 52 in a conventional manner.

As shown in FIG. 3, the chamber 52 is sized to hold a cartridge 70 ofliquid, e.g., drug, to be infused by the pump 14 into a body. The drivemechanism 54 is sized to be received within one end of the liquidcartridge 70 and to engage a plug 72 that forms a movable liquid sealwith the cartridge 70. The opposite end of the liquid cartridge 70 issecured to the housing 50 via releasably engageable, e.g., threaded,adapter 74 through which a conventional Luer lock fitting 76 extends.The Luer lock fitting 76 is configured to be fluidly connected to aninfusion set (not shown) that extends into a body of a user. Under thecontrol of the processor 28, the pump motor 48 drives the liquid drivemechanism 54 to controllably advance into the liquid cartridge 70 andthereby force liquid from the cartridge 70 into the body of the user viathe Luer lock fitting 76 and infusion set.

The user buttons 32 of the liquid infusion pump 14 are distributed ingroups of two buttons or keys 60, 62 and 64, 66 each near opposite sidesof the display unit 34. In the illustrated embodiment, the key 60 is aMENU key, the key 62 is a “check” or “OK” key, the key 64 is an up keyand the key 66 is a down key. The MENU key 60 allows the user to selectand move through menus, function screens and information screens, andmay also act an on/off key for the infusion pump 14. The check or OK key62 allows the user to select menus, to save changes, to exit functionand information screens and to view one or more quick informationscreens. The up key 64 allows the user to move forward in theinformation screens, to increase a displayed setting, to turn on abacklight of the display device 34, to program a quick bolus, to cancela quick bolus and to turn off a stop warning. The stop warning isgenerally activated periodically, e.g., once per minute, when liquiddelivery by the pump 14 is stopped. By pressing and holding the up key64 for approximately 3 seconds, this stop warning may be turned off ordisabled. The down key 66 allows the user to move backward in theinformation screens, to decrease a displayed setting, to program a quickbolus, to cancel a quick bolus and to turn off the stop warning bypressing and holding the down key 36 for approximately 3 seconds. Bysimultaneously pressing the MENU key 60 and the up key 64, the user canexit menus, function screens and information screens without savingchanges, and to sequentially navigate back through the previous menus.By simultaneously pressing the menu key 60 and the down key 66, e.g.,until 3 beeps occur, the user can unlock the user keys 32. Bysimultaneously pressing the up key 64 and the down key 66, the user cancopy an hourly basal rate to the following hour.

The processor 28 is generally operable to control the display unit 34within various menus to allow the user to enter information, such as aninfusion amount, infusion duration, or the like, via one or moreeditable menu screens. By repeatedly pressing the up key 64 or the downkey 66 when an editable menu screen is selected on the display unit 34,the numerical value in the editable menu screen is correspondinglyincremented or decremented respectively. The pump 14 also includes asmart scroll function that provides for rapid scrolling through valuesthat the user may enter in any of the editable menu screens. Forexample, by pressing and holding the up key 64 or the down key 66, thevalue displayed in the editable menu screen is, in one illustrativeembodiment, automatically incremented or decremented respectively at ahigh increment or decrement rate. Alternatively or additionally, thestep size of the increment or decrement may increase to a largerincremental value, e.g., from 0.1 to 0.5, when the up key 64 or the downkey 66 is pressed and held. In either case, the desired value in aneditable menu screen may be selected or confirmed by pressing the OK key62.

EXAMPLE

The following is a description of example features of one illustrativeembodiment of the liquid infusion pump 14 of FIGS. 1-3. It will beunderstood that such features are provided only by way of example, andshould not be considered limiting in any way. By way of overview, theexample infusion pump 14 provides for the choice of three different usermenus of varying complexity. A standard menu provides for basicfunctionality and programming of the pump 14, an advanced menu providesfor full functionality and programming of the pump 14 and a custom menuoption allows the user to define a menu structure having desiredfunctionality and programming options.

Generally, the example infusion pump 14 provides for five basal rateprofiles, and for the programming of three different bolus types.Illustratively, the three different bolus types include a standard (STD)bolus, corresponding to a specified bolus quantity that is deliveredimmediately and all at once, an extended bolus (EXT), corresponding to aspecified bolus quantity that is delivered over a specified period oftime, and a multi-wave bolus (MW), corresponding to a specified bolusquantity of which a portion is delivered immediately and another portionof which is thereafter delivered over a specified time period.Additionally, a quick bolus, which is a specific form of a standardbolus, may also be programmed without having to view the display device34. Warnings and errors are signaled using the combination of audibletones or beeps and tactile vibrations, and the beep tones of the audibledevice 36 are fully adjustable in volume. Historical informationrelating to operation of the pump 14 may be transferred from the pump 14to the electronic device 15 via the wireless communication circuit 35.The display device 34 may be configured to display information in adefault orientation or in an orientation that is rotated 180° relativeto the default rotation. In addition to the warnings and errors, thepump 14 may be programmed to signal various reminders. The user keys 32may be locked to prevent accidental activation of functions, such asduring sleep or certain activities, and may be unlocked using acombination of the user keys 32 as described above.

The screen displayed on the display device 34 relate to four generalcategories: 1) run, stop and quick information, 2) information, 3)function and 4) setup. Generally, the display device 34 is deactivatedby the processor 28 to conserve battery life, and becomes active bypressing any of the user keys 32. When any such key is pressed, the RUNscreen is displayed when the pump 14 is in the RUN mode, meaning thatinsulin is being delivered by the pump 14 according to the programmedbasal rate. Illustratively, the RUN screen displays a basal rateindication icon, the current hourly basal rate, the time of day and theactive basal rate profile. Additional icons that may be displayed on thedisplay device 34 during the RUN mode include, but should not be limitedto, a battery life indicator, a cartridge volume indicator, a pump timerindicator and a key lock indicator.

A STOP screen is displayed when the pump 14 is in the STOP mode, meaningthat insulin is no longer being delivered by the pump 14.Illustratively, the STOP screen displays the current time of day, thedate and a stop symbol. The STOP screen may further be configured todisplay any one or more of a battery life indicator, a cartridge volumeindicator, a pump timer, and a key lock indicator. Illustratively,programming specific functions, changing the cartridge and/or theinfusion set, priming the infusion set, and transferring data to andfrom the pump 14 all require the pump 14 to be in the STOP mode.Additionally, it is illustratively recommended for the pump to be in theSTOP mode when changing the battery 44.

The pump 14 further includes a quick information screen, which may bedisplayed by pressing the OK or check key 62. Generally, the quickinformation screen shows the remaining liquid content in the cartridge70 in suitable liquid units. By again pressing the OK or check key 62,the bolus data function is displayed, and the most recent 30 boluses maybe viewed by pressing the up and down keys 64 and 66 respectively.

The screens displayed on the display device 34 may generally benavigated by pressing the menu key 60 until reaching a screen of choice,and then pressing the OK or check button 62. After pressing the OK orcheck button 62, one or more function screens become available. Thevalue displayed within each function screen may be changed by pressingthe up and down keys 64 and 66 respectively, and the next functionscreen may be displayed by pressing the menu key 60. A user may alsomove backwards through the menu structure as described hereinabove. Inany case, the OK or check button 62 may be pressed to save changes.

Information relating to operation of the pump 14 is generally stored inmemory by the processor 28 along with the time and date of occurrencethereof. Illustratively, the time may be selected to be American time orEuropean/military time. In embodiments in which the pump 14 communicateswirelessly with the electronic device 12 as illustrated in FIG. 1, thetime and date of the pump 14 is the master time and date, and is used toperiodically update the time and date of the electronic device 12.

Basal Rate Profile

In this example, the pump 14 delivers liquid every three minutes, in 20equal doses each hour, 24 hours per day. The flow of liquid, e.g.,insulin, is measured in international units per hour (U/h), and iscalled the basal rate profile. The pump 14 can store up to fivedifferent basal rate profiles each consisting of 24 different hourlybasal rates. Each hourly basal rate may be changed independently, andthe total of all 24 basal rates in any one basal rate profile isreferred to as the daily basal rate total. By pressing the menu key 60,basal rate profile programming screens are available in which basalrates may be programmed for each hour of consecutive 24 hour periods.The basal rate programming screens further allow for the copying ofhourly basal rates to one or more additional hours for situations inwhich the basal rate will be unchanged for multiple consecutive hours.Changes to the basal rate programming screens may be made in either theRUN mode or the STOP mode. These changes are saved by pressing the OK orcheck key 62. If changes are made in the RUN mode, the display device 34returns to the RUN screen after pressing the OK or check key 62. Ifchanges are made in the STOP mode, the display device 34 returns to theSTOP screen after pressing the OK or check key 62. If the user does notpress the OK or check key 62 when attempting to make changes to a basalrate, the screen timer will eventually time out and the processor 28will return the display device 34 to the RUN or STOP screen withoutimplementing the change to the basal rate. Generally, changes may beundone by simultaneously pressing the menu key 60 and the up key 64 whenthe display device 34 returns to the main menu or to the RUN or STOPscreen. During normal use, the pump 14 is in the RUN mode, and liquid,e.g., insulin, is continually delivered to the user's body according tothe programmed basal rate profile. Bolus amounts may be programmed anddelivered as deemed necessary by the user, as will be describedhereinafter.

The display screens of the pump 14 include a START and a STOP screenthat may be accessed by successively pressing the menu key 60. After theuser starts the pump 14 by accessing the START menu and pressing the OKor check key 62, the RUN screen is thereafter displayed. Likewise, byaccessing the STOP screen via successively presses of the menu key 60,the STOP function may be activated by pressing the OK or check button62, after which the STOP screen is displayed on the display device 34.

The liquid infusion pump 14 further provides for the temporary increaseor decrease of the programmed basal rate. For example, a basal rateinitially set to 100% can be increased up to 250% for up to 24 hours ordecreased down to 0% for up to 24 hours, although other percentageand/or time values may be used. In one alternative embodiment, forexample, a basal rate initially set to 100% may be increased up to 500%for up to 50 hours or decreased down to 0% for up to 50 hours. Byincreasing or decreasing the basal rate by the temporary basal rateamount, each hourly basal rate for the duration of the increase ordecrease is likewise increased or decreased. The characteristic shape ofthe existing basal rate profile remains intact with the temporary basalrate. A temporary basal rate may be programmed only when the pump is inthe RUN mode, and is implemented by successively pressing the menu key60 to a temporary basal rate screen. By pressing the OK or check key 62,the temporary basal rate percentage value may be changed by pressing theup or down key 64 or 66 respectively. The duration of the temporarybasal rate may be set by similarly accessing a temporary basal rateduration screen, and setting the duration value to a desired temporarybasal rate duration.

The temporary basal rate may be canceled during programming in one ofthree ways. First, failure to press any of the user keys 32 for 20seconds will cause the pump 14 to return to the RUN screen.Additionally, the temporary basal rate screen may be exited bysimultaneously pressing the menu key 60 and the up key 64. Finally, thetemporary basal rate percentage may be set to the default value of 100%,after which the temporary basal rate value may be saved by pressing theOK or check key 62. During delivery, there are two ways to cancel atemporary basal rate. For example, the temporary basal rate programmingscreen may be accessed, and the temporary basal rate value may bechanged to 100% as described above. Alternatively, the pump 14 may beput into the STOP mode as described above, which automatically cancelsthe temporary basal rate being delivered. A temporary basal rate cancelwarning is displayed in each case, which may or may not be accompaniedby an audible and/or vibratory indication.

Programming Boluses

It is generally understood that a bolus is an amount of insulindelivered to compensate for the intake of food and/or to correct highblood glucose levels. The liquid infusion pump 14 is capable of beingprogrammed to deliver three different types of bolus as described above.Illustratively, the three different bolus types include a standard (STD)bolus, corresponding to a specified bolus quantity that is deliveredimmediately and all at once, an extended bolus (EXT), corresponding to aspecified bolus quantity that is delivered over a specified period oftime, and a multi-wave bolus (MW), corresponding to a specified bolusquantity of which a portion is delivered immediately and another portionof which is thereafter delivered over a specified time period.Additionally, a quick bolus, which is a specific form of a standardbolus, may also be programmed without having to view the display device34.

The liquid infusion pump 14 provides for two different types of standardbolus as just described. A quick bolus may be programmed when the pump14 is operating in the RUN mode by pressing and holding the up key 64 orthe down key 66 for several seconds until a beep sequence and vibrationoccur. Thereafter, a quick bolus screen appears on the display device34, and the user may press the up key 64 or the down key 66 to incrementthe displayed bolus amount until the desired bolus value is reached.Generally, if the up key 64 was used to enter the quick bolus screen,the down key 66 must be used to increment the desired bolus value, andvice versa. In either case, each press of the up key 64 or the down key66 causes the pump 14 to simultaneously beep and vibrate to indicate theincremental increase in the bolus amount. Five seconds after the lastpress of the up key 64 or the down key 66, the pump 14 confirms thetotal quick bolus amount by activating one beep and vibration for eachbolus increment that was programmed. The standard bolus symbol in thedisplay 34 then blinks for approximately five seconds, after which thepump 14 begins to deliver the programmed quick bolus. After the delayperiod, the pump 14 beeps and vibrates three times and then begins todeliver the total quick bolus that was programmed, and the display 34simultaneously counts down the remaining bolus to be delivered until thefull programmed quick bolus amount is delivered. Because the pump 14beeps and vibrates to guide the user through the programming steps, thequick bolus amounts may be programmed without viewing the pump display34.

During programming, the quick bolus amount may be canceled bydecrementing the quick bolus amount to 0.0 units using the opposite oneof the up or down key 64, 66 that was used to increment the quick bolusamount. If the display remains at 0.0 units for approximately fiveseconds, no new bolus will be delivered and the pump display 34 returnsto the RUN screen which may or may not be accompanied by an audibleand/or vibratory indication. The quick bolus may also be canceled duringconfirmation of the total bolus amount (when one beep and vibrationoccurs for each bolus increment programmed) or during start delay (whenthe standard bolus symbol blinks for approximately five seconds), bypressing either of the up or down keys 64 and 66 respectively. When thisoccurs, the display device 34 returns to the RUN screen, and a boluscancel warning then appears on the screen which may or may not beaccompanied by an audible and/or vibratory indication. The user maypress the OK or check key 62 twice to confirm and turn off the alert.The quick bolus may also be canceled during bolus delivery by pressingeither the up key 64 or the down key 66 for approximately three seconds,after which the display 34 will display a bolus cancel warning which mayor may not be accompanied by an audible and/or vibratory indication. TheOK or check key 62 may be pressed twice to confirm and turn off thealert. The actual bolus amount delivered prior to being canceled may beviewed by accessing the bolus history as will be described hereinafter.

A standard bolus may be programmed by accessing the standard bolus menuvia successive presses of the menu key 60. Pressing the OK or check key62 when the standard bolus menu is displayed causes a standard bolusamount to be displayed on the display device 34. The user may press theup key 64 to increase or the down key 66 to decrease the bolus amount,and the OK or check key 62 is pressed to confirm the bolus amount. Afterpressing the OK or check key 62, the display device 34 may be controlledto indicate the change, for example by flashing the standard bolussymbol in the display 34 for some time period, e.g., for approximatelyfive seconds, after which the delivery of the standard bolus amount willbegin. The pump 14 may illustratively produce an audible and/orvibratory indication when the programmed bolus amount is beingdelivered, and the display 34 counts down the remaining bolus yet to bedelivered.

During programming of the standard bolus, cancellation of the bolus mayoccur in one of three ways. If no key is pressed for approximately 20seconds during programming, no bolus amount will be delivered and thedisplay 34 returns to the previous screen. Also, if during programmingof the standard bolus amount, the menu key 60 and the up key 64 aresimultaneously pressed, the pump 14 exits the standard bolus menu andreturns to the previous screen. Finally, if the bolus amount is set to0.0 units, pressing the OK or check key 62, will return the display 34to the previous screen with no bolus amount being delivered. In any ofthese cases, the user may then press the up key 64 three times todisplay the RUN screen or wait until the screen timer times out afterwhich the processor 28 will automatically display the RUN screen. Duringthe start delay (when the standard bolus symbol blinks for approximatelyfive seconds) the programmed standard bolus amount may be canceled bypressing the up key 64 or the down key 66 until a beep sequence isheard, after which the display 34 displays a bolus cancel warning.Pressing the OK or check key 62 twice confirms and turns off this alert.During delivery of the programmed standard bolus amount, the user maypress and hold the up key 64 or the down key 66 for approximately threeseconds until a beep sequence is heard. A bolus cancel warning willagain appear, and the OK or check key 62 may be pressed twice to confirmand turn off this alert. The actual bolus amount delivered prior tocancellation can be viewed by accessing the bolus history as will bedescribed hereinafter.

Extended boluses may be programmed in intervals, e.g., 15, 30 or 60minute intervals, up to some number of time units, e.g., 50 hours, andwill begin immediately after confirmation of the programmed bolusamount. Throughout delivery of an extended bolus, the remaining time andbolus amount yet to be delivered will be displayed, along with thecurrent hourly basal rate, on the display 34 in the RUN screen. Anextended bolus may be programmed by accessing an extended bolus screenvia successive presses of the menu key 60, and then by pressing the OKor check key 62 when the extended bolus appears. The bolus amount may beselected by pressing the up key 64 to increase the bolus amount or byselecting the down key 66 to decrease the bolus amount. The duration ofthe last extended bolus that was delivered appears on the screen, and bypressing the menu key 60 the display 34 displays the bolus durationscreen. The bolus duration may be increased or decreased by pressing theup key 64 and the down key 66 respectively. Successive pressing the menukey 60 will switch the display 34 between the programmed bolus amountand programmed bolus duration. When the extended bolus amount andextended bolus duration are selected, the OK or check key 62 is pressedto confirm the bolus amount and duration. A beep sequence and/orvibration may occur when the OK or check key 62 is pressed. Bolusdelivery thereafter begins, e.g., within the next three minutes. If atemporary basal rate is active at the same time as an extended bolus,the remaining time and amount of the bolus as well as the amount of theincreased or decreased hourly basal rate will be displayed together onthe RUN screen. A standard bolus can be added to an ongoing extendedbolus, and if the standard bolus is canceled, the extended bolus willcontinue to run. However, during the delivery of an extended bolus, theprogramming of another extended bolus or of a multi-wave bolus will beblocked, and an error message indicating that a bolus is currentlyrunning will appear on the display 34. To program a different extendedbolus when an extended bolus is currently running, the pump 14 must beput into the STOP mode to cancel the current extended bolus and then toreprogram a new extended bolus.

An extended bolus may be canceled during programming identically asdescribed hereinabove with respect to the standard bolus. After deliveryof the bolus has begun, the extended bolus may be canceled only byputting the pump 14 in the STOP mode. This cancels delivery of thestandard bolus, and displays a bolus cancel warning in the display 34.The OK or check key 62 may be pressed twice to confirm and turn off thealert. The amount of extended bolus delivered prior to the cancellationmay be viewed in the bolus history screen as will be describedhereinafter.

A multi-wave bolus may be programmed in intervals, e.g., 15, 30 or 60minute intervals, for up to some number of time units, e.g., 50 hours.Programming of a multi-wave bolus is only available in the advanced orcustom user menus, as will be described in greater detail hereinafter,and in these menus successive presses of the menu key 60 will displaythe multi-wave bolus screen. Pressing the OK or check key 62 then causesa bolus amount screen to appear, and the user may select the bolusamount by pressing the up key 64 and down key 66 to increase or decreaserespectively the total bolus amount. Illustratively, the first press ofthe up key 64 will cause the bolus duration of the last multi-wave bolusto appear on the screen. When the total bolus amount is programmed, themenu key 60 may be pressed to move to the immediate bolus screen whichdisplays the immediate portion of the multi-wave bolus. Illustratively,the first press of the up key 64 will cause the amount of the lastimmediate portion of a multi-wave bolus to appear on the screen. Theuser may press the up key 64 and the down key 66 to increment anddecrement the immediate bolus amount. The user may then press the menukey 60 again to move to the bolus duration screen by pressing the up key64 and the down key 66. The duration of the extended portion of themulti-wave bolus may be set in increments, e.g., in increments of 15, 30or 60 minutes, up to some number of time units, e.g., 50 hours. Again,the menu key 60 may be pressed repeatedly to switch the display device34 between the bolus amount, immediate bolus and bolus duration screens.When these three values have been selected, the user may press the OK orcheck key 62 to confirm the multi-wave bolus parameters, and the displaydevice 34 may then be controlled to indicate the confirmation, forexample by flashing the multi-wave bolus symbol on the display 34 forsome time period, e.g., approximately five seconds. At the end of thedelay, e.g., a five second delay, the immediate portion of themulti-wave bolus will be delivered by the pump 14. This may or may notbe accompanied by an audible and/or vibratory indication. The display 34will then be controlled to display a count down of the remaining portionof the bolus.

The multi-wave bolus may be canceled during the programming modeidentically as described with respect to the programming of the standardand extended bolus. During the START delay (in which the multi-wavebolus symbol illustratively flashes), the multi-wave bolus may becanceled identically as described above with respect to the standardbolus. Likewise, the immediate portion of the multi-wave bolus may becanceled during delivery thereof identically as described above withrespect to the standard bolus. Finally, cancellation of the multi-wavebolus during delivery of the extended portion of the multi-wave bolusmay be canceled identically as described above with respect to deliveryof the extended bolus.

Insulin delivery may stop if a mechanical or an electrical error isdiscovered during the routine automatic system check. Insertion of a newbattery will also cause a power interrupt error to occur if the pump 14is operating in the RUN mode. A user may turn off either the beeps orvibrations for the initial alarm indication, but not both. Generally, ifa warning or error is not confirmed by the user in 60 seconds, it willoccur again. The OK or check key 62 will generally be pressed twice toconfirm a warning or an error. The first press acknowledges the warningor error, and the second press confirms the warning or error. If thewarning or error is acknowledged but not confirmed, e.g., by pressingthe OK or check key 62 only once, the warning or error will not becleared and it will generally occur again. If the warning or error isacknowledged and confirmed, e.g., by pressing the OK or check key 62twice, the warning or error will be cleared and will not occur againunless the condition that caused the warning or error thereafter occurs.

The user may turn off the beeps and vibrations by pressing the OK orcheck key 62, after which the warning or error continues to be displayedon the display device 34. By pressing the OK or check key 62 again, thewarning or error will disappear from the display 34. If more than onewarning and/or error occurs simultaneously, the user will be required topress the OK or check key 62 twice for each warning or error to confirmand turn off. However, a number of warnings or errors will continue tobe displayed in the RUN screen or the STOP screen after they have beenconfirmed. Examples of such warnings or errors that will be continued tobe displayed in the RUN screen or STOP screen include, but may not belimited to, a cartridge low warning, a cartridge empty error, a batterylow warning, a battery depleted error, a pump timer warning, and an endof operation error.

The following is a list of warnings and errors that will be identifiedand displayed by the pump 14, each followed by a short descriptionthereof.

A cartridge low warning will occur when the contents of the cartridge 70have dropped to approximately 20 units of insulin.

A battery low warning will occur when the voltage supplied by thebattery 44 is less than a threshold voltage. Failure to replace thebattery will generally result in additional error messages.

When the pump 14 has been without power for more than one hour, a reviewtime warning will occur. With this warning, the user is prompted tocheck and correct if necessary, the current date and time.

When the pump 14 is coming to the end of its predetermined lifetime, alifetime error will occur. Related to this is a pump lifetime timerwarning that will occur when the operating time of the pump 14 will soonexpire. When this error occurs, the display 34 may or may not beactivated to display an approximate number of days remaining in theoperation of the pump 14. In this embodiment, when the pump lifetimetimer reaches zero, the pump 14 will change to the STOP mode and nolonger operate. Alternatively, the pump 14 may be configured to operateafter the pump lifetime timer reaches zero as will be describedhereinafter with respect to FIG. 5.

When a temporarily increased or decreased basal rate has been canceled,a temporary basal rate cancellation warning will occur. Similarly, whena temporary basal rate has ended, a temporary basal rate over warningwill occur, and the original basal rate (100%) will resumeautomatically.

When a bolus has been canceled during the start delay or after deliveryhas begun, as described hereinabove, a bolus cancellation warning willoccur.

If authentication data associated with the pairing and authentication ofan electronic device 12 is or becomes corrupt, or if operation of thewireless communication module 30, illustratively provided in the form ofa BlueTooth® module, is compromised, operation of the pump 14 thereafterwill result in a wireless communication fault warning. This warninggenerally will not occur after pump 14 is either re-paired with theelectronic device 12 to which it was previously paired, or after thepump 14 is paired with a new electronic device.

When the insulin cartridge 70 is empty, a cartridge empty error willoccur. Similarly, if the battery 44 is depleted, a battery depletederror will occur.

If no keys are pressed within a specified time period in the RUN mode,an automatic off error will occur if this feature of the pump 14 isactivated.

On some occasions, insulin may not be delivered by the pump 14 as aresult of a blocked infusion set, a damaged cartridge 70, and/or a dirtyor damaged piston rod. In this case, an occlusion error will occur.Similarly, cartridge change function was not correctly performed, acartridge error will occur, and if the cartridge has been changed butthe infusion set has not been primed, a set not primed error will occur.

If data transfer via the wireless communication circuit 35 has beeninterrupted, a data interruption error will occur.

Additionally, a number of different alarm clock functions may beprogrammed in the pump 14, and an alarm error will occur when any of theprogrammed alarm clock functions expires.

Generally, it will be understood that the occurrence of any of theerrors or warnings described herein by example, may or may not beaccompanied by any type of message displayed on the display device 34,any single one of, plurality of or sequence of an audible indicationand/or any single one of, plurality of or sequence of a vibratoryindication.

Viewing Pump Data

The external pump history (PH) memory unit 29 of the pump 14 storeshistorical information associated with the operation of the pump 14. Thepump history information may include, for example, but should not belimited to, all events relating to the operation of the pump 14, e.g.,warnings and errors, programming operations and insulin deliveryrecords. Up to approximately 4500 events may be stored, whichcorresponds to approximately the previous 90 days of use. This data maybe downloaded to the electronic device 15 via the wireless communicationcircuit 35 as described hereinabove. While still present within the PHmemory unit 29, the following data categories can be reviewed directlyon the display device 34: 1) bolus history (last 30 boluses), 2) alarmhistory (last thirty warnings and errors), 3) history of daily insulintotals (last 30 daily totals of insulin delivered), and 4) temporarybasal rate history (last 30 increases and decreases in basal rate).Additionally, if the pump 14 is configured to do so, the pump timer(remaining timing days until the pump timer expires) information may bereviewed via the display device 34. Generally, the menu key 60 may besuccessively pressed to display a “my data” screen from which theforegoing pump data categories may be accessed. In the bolus historyscreen, for example, the bolus amount and type, bolus time, date andentry number may be displayed. In the alarm history screen, the numberand type of the warning or error may be displayed along with a textdescription of the warning or error, the time, date and entry number ofthe warning or error. In the daily insulin total history screen, totaldaily insulin delivered by date and entry number may be displayed, andin the temporary basal rate history screen, the temporary basal rateincrease or decrease (in percentage), total basal rate duration, timeand date may be displayed. In the pump timer screen, the total number ofdays remaining of pump operation are displayed.

The pump 14 additionally has a data transfer menu that may be accessedthrough repeated presses of the menu key 60 and when the data transfermenu is selected, the user may press the OK or check key 62 to enableddownloading of information to the electronic device 15. Generally, theelectronic device 15 will include one or more software applicationsconfigured to request the downloading of pump data from the PH memoryunit 29 to the electronic device 15 via the wireless communicationcircuit 35.

Available Menus

More or fewer of the foregoing menus are available on the pump screendepending upon which of three menus are selected for use. The threechoices are standard, advanced and custom. If the standard menu isselected, all menus required for the basic functions for the pump 14will be available to the user via the display 34. If the advanced menuoption is selected, the complete range of functions of the pump 14 areprovided in menus available to the user via the display 34, and in thecustom menu option, the user may select which menu is available from thefull range of menus. The user may select the standard, advanced orcustom menu settings by successively pressing the menu key 60 to a menusettings display. If the standard user menu is selected, the followingmenu settings are available; therapy settings, pump settings, time anddate settings, and my data. In the RUN mode, the programmed basal rate,stop command, standard bolus, extended bolus, temporary basal rate andbasal rate programming displays are available. In the STOP mode, theSTOP display, start pump, cartridge change, infusion set priming, datatransfer and basal rate one through five selection screens areavailable. In the advanced user menu setting, the following menusettings are available: Bluetooth settings, therapy settings, pumpsettings, time and date settings, reminder settings and my data. In theRUN mode, the basal rate display, stop command, standard bolus, extendedbolus, multi-wave bolus, temporary basal rate programming and basal rateprofiles one through five programming screens are available. In the STOPmode, the stop display, start command, cartridge change, infusion setpriming, data transfer and basal rate one through five selection screensare available. In the custom menu setting, the desired ones of theadvanced menu settings may be selected for display.

Referring now to FIG. 4, a flowchart is shown of one illustrativeembodiment or process for controlling change access to one or moreactive items of a menu display of the display device 34 of the insulininfusion pump 14. In one embodiment, the process 80 is illustrativelystored within the memory unit 25 of the processor 28, or in either ofthe memory units 27 and 29, in the form of instructions that areexecutable by the processor 28 to carry out the features of the process80. In an alternate embodiment, the process 80 is illustratively storedin a memory unit of the electronic device 15 in the form of instructionsthat are executable by a processor of the electronic device 15 to carryout the features of the process 80. In this latter embodiment, theelectronic device 15 is illustratively a PC, laptop or notebookcomputer, although the electronic device 15 may alternatively be anyconventional computer, hand-held electronic device or other conventionalelectronic device. While the process 80 will be described with respectto FIG. 4 as being carried out on the liquid infusion pump 14, i.e.,executed by the processor 28, it will be understood that the process 80may alternatively be carried out on the electronic device 15, i.e.,executed by a processor included in the electronic device 15.

In the illustrated embodiment, the process 80 presumes that a menu fordisplay on the display device 34 of the liquid infusion pump 14 has beenprogrammed and stored in the memory unit 25. At step 82 of the process80, the processor 28 is operable to control the display device 34 todisplay the program menu thereon. Following step 82, the processor 28 isoperable at step 84 to monitor a menu lock flag that is stored in thememory unit 25, or alternatively in the memory unit 27 or 29. Thereafterat step 86, the processor 28 is operable to determine the status, e.g.,locked (activated) or unlocked (deactivated), of the menu lock flagstored in the memory unit 25.

If the processor 28 determines at step 86 that the menu lock flag islocked or activated, the processor 28 is operable at step 88 to disablechanges to any one or more of the active menu items of the currentlydisplayed menu. In one illustrative embodiment, step 88 may furtherinclude the act of displaying via the display device 34 a warningmessage, that may or may not be accompanied by an audible or vibratoryindication, upon detection of attempted changes to the one or moreactive menu items of the currently displayed window when the menu lockflag is locked or activated. If, at step 86, the processor 28 determinesthat the menu lock flag status is unlocked or deactivated, the processor28 is thereafter operable at step 90 to enable changes to one or moreactive menu items in the currently displayed menu. At either of steps 88or 90, the process 80 ends.

Illustratively, a different menu lock flag exists for eachpre-programmed menu of the liquid infusion pump 14. Alternatively, asingle menu lock flag may exist for all of the pre-programmed menus ofthe liquid infusion pump. In one embodiment, all of the one or more menulock flags are initially locked or activated so that a user may notchange one or more active menu items of any of the displayable menus. Inone embodiment, the menu lock flag for any one or more of thedisplayable menus may be unlocked or deactivated by entering a suitablecode or password into processor 28 via one or more of the user keys 32.Such a password may, for example, be known to a healthcare provider orother restricted person who may unlock or deactivate the menu lock flagfor one or more menus so that one or more such menus may be customizedfor the user. Unlocking or deactivating any such menu lock flag mayillustratively allow the healthcare professional or other restrictedperson to modify one of a certain one or more active menu items of anydisplayed menu, or may alternatively unlock or deactivate all activemenu items of the selected display so that the healthcare professionalor other restricted person may modify any active display item.

In an alternative embodiment, two different versions of applicationsoftware containing the menu or menus may exist; one that is availableto users and another that is available only to health careprofessionals. In this embodiment, the menu lock flag is illustrativelyactivated in the version that is available to users so that users do nothave change access to one or more active menu items in one or moremenus, and illustratively deactivated or non-existent in the versionthat is available to health care professionals so that health careprofessionals do have change access to the one or more active menu itemsin one or more menus. In this embodiment, the version that is availableto users may, but need not, provide for menu change access by entering asuitable password or other access code.

Referring now to FIG. 5, a flow chart is shown of one illustrativeembodiment of a process 100 for extending the preprogrammed lifetime ofthe liquid infusion pump 14. In one embodiment, as describedhereinabove, the pump 14 includes a pump lifetime timer that allows thepump 14 to operate for a predetermined time, e.g., four years, afterwhich operation of the pump 14 is disabled. In the embodimentillustrated in FIG. 5, in contrast, operation of the pump 14 may beextended beyond expiration of the pump lifetime timer. The process 100is illustratively stored in the memory unit 25, or in the memory unit 27or 29, in the form of instructions that are executable by the processor28 to carry out the various features of the process 100.

The process 100 begins at step 102 where the processor 28 monitors thepump lifetime timer. Thereafter at step 104, the processor 28 isoperable to determine whether the lifetime timer has expired. If not,the process 100 loops back to step 102. If, at step 104, the processor28 determines that the pump lifetime timer has expired the process 100advances to step 106 where the processor 28 is operable to control thedisplay device 34 to display a message indicating that the pump 14 haspassed its lifetime. Thereafter at step 108, the processor 28 isoperable to control the audible indicator 36 and/or the vibratory device38 to provide a corresponding audible and/or vibratory indication whenthe lifetime timer expires. Step 108 is illustrated in FIG. 5 as adashed-line step to indicate that this step is optional. In any case,the process 100 advances to step 110, where the processor 28 is operableto determine whether an operating error associated with the operation ofthe pump 14 has been detected. Illustratively, the operating errormonitored at step 110 may be or include any one or more of the pumperrors described hereinabove. If such an error is not detected, theprocess 100 loop back to the beginning of step 110. If, at step 110, theprocessor 28 determines that an operating error has been detected, theprocess 100 advances from step 110 to step 112, where processor 28 isoperable to disable, e.g., permanently, operation of the pump 14.Following step 112, the process 100 ends.

Referring now to FIG. 6, a flowchart is shown of one illustrativeembodiment of a process 120 for periodically storing pump operatinginformation in the non-volatile PD memory unit 27 during delivery ofliquid by the liquid infusion pump 14. The process 120 is illustrativelystored in the memory unit 25, or in the memory unit 27 or 29, in theform of instructions that are executable by the processor 28 to carryout the process 120. The process 120 begins at step 122 where theprocessor 28 is operable to determine whether the liquid infusion pump14 is currently delivering liquid, either as a result of being locallycommanded to deliver liquid or of being remotely commanded to do so. Ineither case, if the processor 28 determines at step 122 that the liquidinfusion pump 14 is not currently delivering liquid, the process 120loops back to the beginning of step 122. If, at step 122, the processor28 otherwise determines that the liquid infusion pump 14 is currentlydelivering liquid, the process 120 advances to step 124 where theprocessor 28 is operable to periodically store pump operatinginformation in a predefined storage location of the non-volatile pumpdelivery (PD) memory unit 27. Alternatively, the processor 28 may beoperable at step 124 to periodically store the pump operatinginformation in a predefined storage location of the non-volatile pumphistory (PH) memory unit 29. Illustratively, the term “periodically” maybe time-based and may be any time value between a few microseconds andone or more seconds. Alternatively or additionally, the term“periodically” may correspond to units or sub-units of liquid that isdelivered by the liquid infusion pump 14. One specific example of theformer case may be 1-10 milliseconds, and one specific example of thelatter case may be 1/10-½ units of liquid, e.g., IU, although neither ofthese examples should be considered to be limiting in any way. In anycase, the term “pump operating information” may be or include, butshould not be limited to, delivered liquid quantity, e.g., in IU, apercentage of a delivered liquid quantity relative to 100%, one or moreassociated liquid delivery limits, e.g., maximum and/or minimum quantityand/or duration, delivery type (or profile), e.g., basal, temporarybasal, standard bolus, extended bolus, multi-wave bolus, quick bolus orthe like, whether the delivered liquid was locally or remotelycommanded, time and date of liquid delivery, and the like.

Following step 124, the processor 28 is operable at step 126 todetermine whether the current liquid delivery profile is complete, i.e.,whether delivery of the currently commanded liquid delivery type iscomplete. If not, the process 120 loops back to the beginning of step124. If, at step 126, the processor 28 determines that the currentliquid delivery profile is complete, the process 120 advances to step128 where the processor 28 transfers all of the pump operatinginformation relating to the currently commanded liquid delivery profilefrom the predefined location of the non-volatile memory unit 27 to apump history database resident in the non-volatile PH memory unit 29.Alternatively, the pump history database may be resident in thenon-volatile memory unit 27 at a location that is different from that ofthe current pump operating information. In any case, the process 120advances from step 128 to step 132 where the processor 28 is operable toclear the predefined location of the non-volatile memory unit 27 tothereby remove the pump operating information relating to the currentlycommanded liquid delivery profile from the non-volatile memory unit 27.The process 100 ends after the completion of step 132.

The processor 28 is operable according to the process 120 just describedto illustratively store in a predefined location of the non-volatilememory unit 27 pump operating information that relates to a liquiddelivery profile that is currently being delivered by the pump 14. Afterdelivery of the profile is complete, the processor 28 illustrativelytransfers the pump operating information relating the completed deliveryprofile from the predefined location of the non-volatile memory unit 27to the pump history database in the non-volatile memory unit 29. Onepurpose for periodically storing the pump operating information as thecommanded liquid amount is being delivered is to retain pump operatinginformation in the event of a power down or power failure of the pump14. Illustratively, the on/off function (e.g., the menu key 60) isdisabled so that the pump 14 cannot be turned off during delivery ofliquid. However, a power failure may occur that relates to the one morebatteries 44 and/or power supply circuit 42 and that causes disruptionof electrical power supplied by the power supply circuit 42 to theprocessor 28. Likewise, power supplied by the power supply circuit 42 tothe processor 28 will be disrupted if the one or more batteries 44is/are removed. In either case, current liquid delivery information isretained by periodically storing the pump operating information in thenon-volatile memory unit 27 as the commanded liquid amount is beingdelivered.

Because such a power failure or power disruption may occur at any time,the process 120 further includes an additional step 130 that isrepeatedly executed by the processor 28. At step 130, the processor 28is operable to determine whether the pump 14 has just powered up. If theprocessor 28 determines that the pump 14 has not just powered up, theprocess 120 loops back to the beginning of step 130. If, at step 130,the processor 28 determines that the pump 14 has just powered up, step130 advances to step 128 where the processor 28 is operable to transferany pump operating information that corresponds to current delivery ofliquid from the predefined location of the non-volatile memory unit 27to the pump history database resident within the non-volatile memoryunit 29. During normal operation of the pump 14, the predefined locationof the non-volatile memory unit 27 generally will not have anyinformation stored therein upon power up of the pump 14 that relates toliquid currently being delivered by the pump 14, and in such cases theexecution of step 128 after power up of the pump 14 will not result inthe transfer of any current liquid delivery information from thepredefined location of the non-volatile memory unit 27 to the pumphistory database resident within the non-volatile memory unit 29.However, in cases where a power failure or disruption occurs asdescribed above, execution of step 128 following subsequent power up ofthe pump 14 will typically result in the transfer of current liquiddelivery information from the predefined location of the non-volatilememory unit 27 to the pump history database resident within thenon-volatile memory unit 29 if the pump 14 was delivering liquid at thetime of the power failure or disruption. The current liquid deliveryinformation that is transferred at step 128 will, in such cases,correspond to the liquid delivery information that was accumulated inthe predefined location of the non-volatile memory unit 27 prior to thepower failure or disruption.

While the invention has been illustrated and described in detail in theforegoing drawings and description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly illustrative embodiments thereof have been shown and described andthat all changes and modifications that come within the spirit of theinvention are desired to be protected. For example, while variousoperations of the liquid infusion pump 14 have been described herein asbeing accompanied by a general or specific display on the display device34, a general or specific audible indication and/or a general orspecific vibratory indication, it will be understood that the enteringof any information into the pump 14, any wireless communication with thepump 14 and/or any operation carried out by the pump, delayed orotherwise, including but not limited to basal or bolus delivery, errorconditions, warning conditions, or the like, may or may not beaccompanied by any type of message displayed on the display device 34,any single one of, plurality of or sequence of an audible indicationand/or any single one of, plurality of or sequence of a vibratoryindication.

1. A method of controlling change access to a display menu of anambulatory liquid infusion pump, the method comprising: displaying aprogrammed menu of the infusion pump, monitoring a menu lock flag, anddisabling changes to at least one active item of the programmed menu ifthe menu lock flag is activated.
 2. The method of claim 1 whereindisabling changes comprises disabling changes to all active items of theprogrammed menu.
 3. The method of claim 1 further comprising displayinga warning message upon detection of attempted changes to the at leastone active item of the programmed menu if the menu lock flag isactivated.
 4. The method of claim 1 further comprising enabling changesto the at least one active item of the programmed menu if the menu lockflag is deactivated.
 5. The method of claim 1 wherein enabling changescomprises enabling changes to all of the active items of the programmedmenu.
 6. The method of claim 1 wherein the method is carried out on theambulatory liquid infusion pump, and wherein displaying comprisesdisplaying the programmed menu on a display device of the ambulatoryliquid infusion pump.
 7. The method of claim 1 wherein the method iscarried out on an electronic device that is separate and remote from theambulatory liquid infusion pump, and wherein displaying comprisesdisplaying the programmed menu on a display device of the electronicdevice.
 8. The method of claim 1 wherein a first version of applicationsoftware containing the menu is available to users of the ambulatoryliquid infusion pump and a second version of the application softwarecontaining the menu is available only to health care professionals, andwherein the menu lock flag is activated in the first version ofapplication software and is deactivated in the second version of theapplication software.
 9. The method of claim 1 wherein a first versionof application software containing the menu is available to users of theambulatory liquid infusion pump and a second version of the applicationsoftware containing the menu is available only to health careprofessionals, and wherein the menu lock flag is activated in the firstversion of application software, and wherein the second version of theapplication software does not include the menu lock flag.
 10. A methodof extending a pre-programmed lifetime of an ambulatory liquid infusionpump, the method comprising: monitoring a pre-programmed lifetime timerresident in the liquid infusion pump, allowing the liquid infusion pumpto continue operating after the lifetime timer expires, and disablingoperation of the liquid infusion pump if a liquid infusion pumpoperating error is detected after the lifetime timer expires.
 11. Themethod of claim 10 further comprising displaying a message on a displaydevice of the liquid infusion pump when the lifetime timer expires. 12.The method of claim 11 wherein the message identifies expiration of thelifetime of the liquid infusion pump.
 13. The method of claim 10 furthercomprising activating at least one of an audible indicator and avibratory device when the lifetime timer expires.
 14. A method ofstoring information relating to operation of a liquid infusion pump, themethod comprising: periodically storing in a storage location of anon-volatile memory information relating to delivery by the pump of acommanded liquid amount throughout delivery by the pump of the commandedliquid amount, transferring the information relating to delivery by thepump of the commanded liquid amount from the storage location of thenon-volatile memory to a pump history database when delivery by the pumpof the commanded liquid amount is complete, and automaticallytransferring any information relating to delivery by the pump of acommanded liquid amount that is accumulated in the storage location ofthe non-volatile memory to the pump history database upon power up ofthe liquid infusion pump.
 15. The method of claim 14 wherein theinformation relating to delivery by the pump of a commanded liquidamount includes any one or more of a delivered liquid quantity, apercentage of a delivered liquid quantity relative to 100%, one or moreassociated liquid delivery limits, a liquid delivery type, whether thedelivered liquid was locally or remotely commanded, and the time anddate of liquid delivery.
 16. The method of claim 15 wherein the one ormore liquid delivery limits includes one or more of a maximum liquidamount, a minimum liquid amount, a maximum delivery duration and aminimum delivery duration.
 17. The method of claim 15 wherein the liquiddelivery type is at least one of a basal rate, a temporary basal rate astandard bolus, an extended bolus, a multi-wave bolus and a quick bolus.18. The method of claim 14 further comprising clearing the non-volatilememory after automatically transferring information from thenon-volatile memory to the pump history database.
 19. The method ofclaim 14 wherein the commanded liquid amount is one of a locallycommanded liquid amount and a remotely commanded liquid amount.
 20. Themethod of claim 14 wherein periodically storing information relating todelivery by the pump of a commanded liquid amount throughout delivery bythe pump of the commanded liquid amount comprises storing informationperiodically in time.
 21. The method of claim 14 wherein periodicallystoring information relating to delivery by the pump of a commandedliquid amount throughout delivery by the pump of the commanded liquidamount comprises storing the information after each delivery of by thepump of an incremental amount of the commanded liquid amount.